Regulatory Developments

As Toxic Substances Control Act (TSCA) aficionados know well, September 19, 2017, is a banner date. By then, information that was submitted and claimed as Confidential Business Information (CBI) between June 22, 2016, and March 21, 2017, must be substantiated. If you have not already done so, the September 19th deadline looms large.

Background

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of TSCA Section 14 concerning substantiation of CBI claims for information submitted to EPA. 82 Fed. Reg. 6522. Under the interpretation, EPA expressed its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA. EPA noted that the action will “facilitate [its] implementation of TSCA section 14(g) to review all CBI claims for chemical identity, with limited exceptions, as well as to review a representative sample of at least 25% of other non-exempt claims.”

The notice states that CBI claims made as part of an existing submission in EPA’s Central Data Exchange (CDX), such as information claimed as confidential in a premanufacture notice (PMN), must be substantiated by amending the CDX submission. Other information should be substantiated using the same mechanism (e.g., substantiate claims made in paper submissions by submitting substantiations on paper). The action was effective as of March 21, 2017, after which any non-exempt CBI claim must be substantiated at the time of submission. Importantly, any CBI claims that are not substantiated will be considered by EPA to be deficient, resulting is EPA’s issuance of a notice to the affected business informing the business that it must remedy the substantiation deficiency within 30 calendar days or the information may be made public.

EPA’s notice outlines the legal and administrative basis for its interpretation that new TSCA requires affected businesses to substantiate all TSCA CBI claims at the time the information is submitted. This substantiation requirement does not apply to Section 14(c)(2) “information [that is] generally not subject to substantiation requirements.” More information on EPA’s interpretation is available in our memorandum EPA Issues Interpretation of Statutory Requirements for Substantiation of CBI Claims under TSCA.

Implementation

If you have not focused on this fast-approaching important deadline, you should do so now. EPA urges businesses to look to the substantiation questions found at 40 C.F.R. Part 2, Section 2.204(e) for guidance as to how to meet the Section 14(c)(3) substantiation requirements for information not currently subject to regulatory requirements for upfront substantiation. EPA states that the answers to those questions typically form the basis of EPA final confidentiality determinations and that substantiations that do not address those questions “might not provide sufficient information to uphold” a TSCA Section 14(g)(1) determination that the information is eligible for CBI protection.

Helpful Tips

Review EPA Templates: EPA has provided templates for substantiating CBI claims in submissions. The templates are available online. These templates are suggested, but not required. If you elect to use a different document to substantiate CBI claims, be sure to address all the elements in the template files. A substantiation document may itself contain CBI. Be sure to indicate what content in the document is CBI and that such claims are also substantiated or note any substantiation exemptions that apply. Include a sanitized copy of the document when the substantiation document is submitted to EPA; CDX will require a sanitized copy of any document that includes a CBI claim.

Review Prior Submissions: Submitters should review all documents submitted between June 22, 2016, and March 21, 2017, for information that was claimed as CBI. In each submission, review each data element claimed as CBI in a Section 5 notice, Chemical Data Reporting (CDR) submission, or other type of document, and consider carefully whether the information is truly confidential. EPA reportedly has found that a surprising number of claims of information thought to be CBI have actually been made public by the submitter on a website or is otherwise publically available. If information is in the public domain, a submitter cannot claim that information as CBI, even elements that might otherwise be exempt under TSCA Section 14(c), as the ability to assert a claim of confidentiality has been deemed waived. Identify any elements that are not confidential and note that you intend to withdraw the CBI claim for those data elements. Note that data elements that were not claimed as CBI in the submission may not be retroactively claimed as CBI.

Review Claims to Assess if Any Are Exempt From Substantiation: Review the remaining data elements claimed as CBI to assess if any are exempt from substantiation under Section 14(c) and note which subparagraph applies to each such claim. Be sure to identify which data elements are exempt and the applicable exemption listed in TSCA Section 14(c). For data elements that are not exempt from substantiation, review each and answer the substantiation questions that are included on the templates, the first of which is to describe the substantial harm to the company’s competitive position that would result from the disclosure of that information. EPA has repeatedly emphasized the need for facts and context in substantiation statements. If multiple data elements are essentially the same information, those common elements can be substantiated with a common statement. For example, if disclosure of the identity of the submitting company would cause substantial harm to the company’s competitive position, the disclosure of a technical contact from that company would also cause substantial harm, as would the identity of the company’s manufacturing site. If any non-exempt claims cannot be substantiated, indicate that you intend to withdraw the CBI claim for those data elements. After this exercise, each CBI claim will be withdrawn, identified as exempt from substantiation, or substantiated. Note that CBI claims for chemical identity in a Section 5 notice require an additional step. A submitter must provide a structurally descriptive generic name for any substance for which the specific identity is claimed as confidential. EPA has long-standing guidance on structurally descriptive generic names.

Once the substantiation document is complete for each submission, that document should be submitted by the same mechanism of the original submission (CDX or paper). If the original submission was a TSCA Section 5 notice, a PMN for example, the substantiation document may be submitted as a support document associated with the original notice in CDX. For other form types (e.g., CDR, Section 8) may be unlocked and amended to include the substantiation document as an attachment. Substantiation of paper submissions should be done on paper. Be sure to identify the original submission so that EPA can properly pair the substantiation with the original.